Second Sight Medical (NSDQ:EYES) announced that it priced an underwritten public offering with expected gross proceeds reaching $7.5 million. The maker of visual prosthetic implants for blind individuals announced in March that it was winding down its operations amid the financial shock of the COVID-19 pandemic. At the time, the company said it would lay off […]
Implants
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
COVID-19 upends medtech’s financial outlook
The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Medtronic’s Pipeline Flex recall is Class I
The FDA has labeled a recall for the Medtronic (NYSE:MDT) Pipeline Flex embolization device and Pipeline Flex embolization device with Shield technology as Class I. Medtronic wrote to customers risk of device fracture in February and later issued an urgent field safety notice to warn on specific production lots. The affected Pipeline Flex devices are available […]
Neocis seeks 510(k) nod for Yomi edentulous splint for robotic dental surgery
Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. The Miami-based company’s new splint is designed to enable the Yomi dental robotic system to go beyond placing implants for partially edentulous patients, with new capabilities for assisting doctors with full arch implant […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
NuVasive recalls scoliosis treatment devices
NuVasive (NSDQ:NUVA) issued an urgent field safety notice to warn users of an issue with the separation of a certain component in its Magec system model X rods. According to the safety notice, post-implant separation of an actuator end cap component was observed in the rods. Data from post-market surveillance revealed that the end cap separation […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]
DePuy Synthes wins CE Mark for hip replacement dual mobility system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes announced that it won CE Mark approval for its Bi-Mentum dual mobility system for people with a higher risk of dislocation. Bi-Mentum is designed with a standard femoral head articulating within a large polyethylene liner that swivels within a metal shell, reducing the risk of dislocation, which can impact patient satisfaction […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Medtronic issues urgent field safety notice for some Pipeline Flex embolization devices
Medtronic (NYSE:MDT) issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolization devices due to the potential for device fracture. The medtech giant initiated verbal communication about the issue last month after identifying the potential for device fracture at the distal section during use, due to a weakened bond […]